Hypertension in PregnancyNCT04748107
Treatment of Severe Hypertension With ICG Directed Therapy
A study testing Impendence Cardiography in people with Hypertension in Pregnancy, run by Marshall University at 1 site in United States.
Trial summary
The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Impendence Cardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressure after 20 weeks gestation. Patients will be English speaking and range in ages from 15-45 years old. Patient's will be consented prior to randomization.
Who cannot join
- Patients presenting to Labor and Delivery at Cabell Huntington Hospital with normal range blood pressures, or those with elevated blood pressures who do not consent to the study, patients <20 weeks gestation, or patients with eclampsia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cabell Huntington Hospital
Huntington, West Virginia, 25701
About this study
Official title: Treatment of Severe Hypertension With Impendence Cardiography (ICG) Directed Therapy; a Randomized Controlled Trial
The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term.
Read the detailed description
Research Protocol
Study Design: Randomized Control Trial This is a randomized control trial comparing the usefulness of impedance cardiography (ICG) directed therapy in treating severe range hypertension (systolic BP >160 OR diastolic BP >110) in patients greater than 20 weeks gestation. All patients in the study will receive standard of care medication within the suggested timeframe by the American College of Obstetrics and Gynecology (ACOG). All patients will receive a hemodynamic assessment prior to receiving and after receiving medications. The treatment patients will receive either labetalol or nifedipine therapy for hypertension based on their hemodynamic parameters. The control group will receive medication based on provider preference (which is the usual plan of care).
Study Population:
Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressures. Consent will be obtained prior to randomization to standard care or ICG directed care. Patient age range will be from age 15 to approximately 45.
Schedule of Assessment:
An interval assessment will be performed after 20 patients have been assessed. The goal is for a total enrollment of 100 patients, 50 to the ICG directed treatment group and 50 to the control group.
Study Procedures:
If a patient presents to Labor and Delivery at Cabell Huntington Hospital and consents to the study, she will be randomized to either the ICG directed therapy group or provider preference group. Patients from each group will receive a non-invasive hemodynamic assessment via the NICaS system. The NICaS system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. The vasodilator nifedipine will be initiated for increased systemic vascular resistance. Elevated cardiac output will be treated with beta blockade via IV labetalol. ACOG recommends either of these medications as first line therapy for elevated blood pressure, and offers no guidance on which medication should be used first. All patients who are being treated will receive the standard of care treatment, however the ICG group will receive therapy based on their hemodynamic parameters.
Study Analysis The control group will be compared to the ICG directed treatment group.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Impendence Cardiography
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impendence CardiographyDiagnostic test
ICG is a noninvasive method of determining the amount of blood flow using the Non-Invasive Cardiac System - Cardiac Surveyor (NICaS) system, which provides an assessment of the cardiovascular system, respiratory system, and fluid retention.
| Study group | Role | What they receive |
|---|---|---|
| Provider preference: Control group | No intervention | Provider will prescribe blood pressure medication based on his professional expertise. |
| ICG directed therapy group | Experimental | ICG directed therapy will be used to determine which blood pressure medication is received. Receives: Diagnostic Test: Impendence Cardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The systolic blood pressure
mmHg
Measured: 1 year
The diastolic blood pressure
mmHg
Measured: 1 year
mean arterial pressure
mmHg
Measured: 1 year
heart rate
beats/minute
Measured: 1 year
cardiac output (L/min)
liters per minute
Measured: 1 year
systemic vascular resistance
dynes · sec/cm^-5
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start25 Apr 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: Too difficult to perform study procedures prior to giving blood pressure medication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to treatment of non treatment group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cottrell, Marshall University
- Investigators
- Jesse Cottrell, MD, Principal investigator, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748107
- Sponsor's protocol ID
- 1605500
- Status last verified
- Jun 2023
- First submitted
- 2 Nov 2020
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Severe Hypertension With Impendence Cardiography (ICG) Directed Therapy; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04748107
- Acronym / sponsor ID
- 1605500
- Conditions
- Hypertension in Pregnancy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too difficult to perform study procedures prior to giving blood pressure medication.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term.
Detailed description
Research Protocol
Study Design: Randomized Control Trial This is a randomized control trial comparing the usefulness of impedance cardiography (ICG) directed therapy in treating severe range hypertension (systolic BP >160 OR diastolic BP >110) in patients greater than 20 weeks gestation. All patients in the study will receive standard of care medication within the suggested timeframe by the American College of Obstetrics and Gynecology (ACOG). All patients will receive a hemodynamic assessment prior to receiving and after receiving medications. The treatment patients will receive either labetalol or nifedipine therapy for hypertension based on their hemodynamic parameters. The control group will receive medication based on provider preference (which is the usual plan of care).
Study Population:
Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressures. Consent will be obtained prior to randomization to standard care or ICG directed care. Patient age range will be from age 15 to approximately 45.
Schedule of Assessment:
An interval assessment will be performed after 20 patients have been assessed. The goal is for a total enrollment of 100 patients, 50 to the ICG directed treatment group and 50 to the control group.
Study Procedures:
If a patient presents to Labor and Delivery at Cabell Huntington Hospital and consents to the study, she will be randomized to either the ICG directed therapy group or provider preference group. Patients from each group will receive a non-invasive hemodynamic assessment via the NICaS system. The NICaS system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. The vasodilator nifedipine will be initiated for increased systemic vascular resistance. Elevated cardiac output will be treated with beta blockade via IV labetalol. ACOG recommends either of these medications as first line therapy for elevated blood pressure, and offers no guidance on which medication should be used first. All patients who are being treated will receive the standard of care treatment, however the ICG group will receive therapy based on their hemodynamic parameters.
Study Analysis The control group will be compared to the ICG directed treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to treatment of non treatment group
| Arm | Type | Receives |
|---|---|---|
| Provider preference: Control group | No intervention | –Provider will prescribe blood pressure medication based on his professional expertise. |
| ICG directed therapy group | Experimental | Diagnostic Test: Impendence CardiographyICG directed therapy will be used to determine which blood pressure medication is received. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressure after 20 weeks gestation. Patients will be English speaking and range in ages from 15-45 years old. Patient's will be consented prior to randomization.
Key exclusion criteria (1 listed)
- Patients presenting to Labor and Delivery at Cabell Huntington Hospital with normal range blood pressures, or those with elevated blood pressures who do not consent to the study, patients <20 weeks gestation, or patients with eclampsia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impendence CardiographyICG is a noninvasive method of determining the amount of blood flow using the Non-Invasive Cardiac System - Cardiac Surveyor (NICaS) system, which provides an assessment of the cardiovascular system, respiratory system, and fluid retention. | Diagnostic test | ICG directed therapy group |
Primary outcome
The systolic blood pressure
Time frame: 1 year
mmHg
The diastolic blood pressure
Time frame: 1 year
mmHg
mean arterial pressure
Time frame: 1 year
mmHg
heart rate
Time frame: 1 year
beats/minute
cardiac output (L/min)
Time frame: 1 year
liters per minute
systemic vascular resistance
Time frame: 1 year
dynes · sec/cm^-5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Cottrell, MD principal investigator
Marshall University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impendence Cardiography in people with Hypertension in Pregnancy, run by Marshall University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The systolic blood pressure (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.